Phathom Pharmaceuticals, Inc.

Hello and welcome to the Fathom Pharmaceuticals fourth quarter and full year 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised today's conference is being recorded. With that, I would like to turn the conference over to Eric Chiarelli, Fathom's Head of Investor Relations. Please go ahead.

Thank you, Operator. Hello, everyone, and thank you for joining us this morning to discuss Fathom's fourth quarter and full year 2023 results. This morning's presentation will include remarks from Terry Curran, our President and CEO, Martin Gilligan, our Chief Commercial Officer, and Molly Henderson, our Chief Financial Officer. Azmi Nabulsi, our Chief Operating Officer, will also be joining the team during the Q&A portion of today's call. Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found under the News Releases section of our corporate website. Further, the recording of today's webcast can be found under the events and presentation section of our corporate website. Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Fathom's control. Actual results can materially differ from the forward-looking statements, and any such risk can materially adversely affect the business, the results of operations, and trading prices for Fathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide, as well as in the risk factors section of our most recent Form 10-K and subsequent SEC filings. All forward-looking statements made on this call are based on the beliefs of FATHOM as of this date, and FATHOM disclaims any obligation to update these statements. Also included today are non-GAAP financial measures, which should be considered only as supplemental to and not a substitute for or superior to GAAP measures. To the extent applicable, please refer to the tables at the end of this morning's press release for reconciliations of these non-GAAP measures to the most directly comparable GAAP measures. With that, I will now turn the call over to Terry Curran, BADM's President and CEO, to kick us off. Terry?

Thank you, Eric, and thank you to all those joining us on today's call. This is our first earnings call as a commercial company, and I'm excited to report on the progress we've made during both the fourth quarter, 2023, and the start of the calendar year, 2024. In that short period, we've achieved many regulatory, manufacturing, financial, and commercial milestones, demonstrating the significant experience and dedication of our teams. In November we set out with three initial goals for the early stages of launch. To communicate the QESNAS clinical superiority versus the PPI, drive awareness with physicians and build access for commercial patients. Today I'm proud to share that we're delivering on those goals. Prescribers have quickly recognized the QESNAS differentiated and novel mechanism of action. Our reps are even sharing stories of physicians echoing the Quesna's rapid, potent and durable acid suppression profile. Excitement is translating into demand with thousands of scripts being written since product became available. After over 30 years since the first PPI was approved, there is strong demand for something new. Further, the number of patients who have used the Quesna is growing daily. For me, this is one of the most rewarding elements of our launch. Through our reps, employees, and sometimes even friends and family, I'm hearing stories of long-suffering patients who are experiencing noticeable improvement with the Quesna. We're working hard to ensure as many patients as possible can access the Quesna and share that experience. In fact, with our recent ExpressGrips win, we're well on our way to securing widespread coverage for commercial patients. These early indicators, along with Benoprazan's massive commercial success in Japan, have reinforced my belief in Bequesna's bright future here in the U.S. With an erosive GERD market of approximately 7 million U.S. adults, positive feedback from physicians and patients, and anticipated label expansions, we remain confident in our belief that Bequesna has the potential to reach annual peak revenues of greater than $3 billion. As for our early launch data, I'm happy to report that over 3,800 prescriptions have been filled for the Quesna products. For clarity, this includes scripts captured by Acuvia as well as those that were filled through BlinkRx. We specify filled because we have simultaneously been monitoring an estimate of total demand. which we believe paints a comprehensive picture of the early and growing position interest in writing the Quesna products. We estimate upwards of 14,000 total prescriptions have been written launched to date. We're pleased with this magnitude of total demand and see it as an indicator of what's on the horizon for the Quesna as we continue pursuing broad payer coverage. Last month, the Quesna was added to express scripts, national formularies, for commercial patients. In line with our goal, we secured placement with a single step edit through a generic PPI. As a result, the Quesna bottle's access expanded to an estimated 60 million commercially covered lives. We believe our ability to obtain commercial formulary placement was one of the nation's largest PBMs so quickly after approval indicates that our pricing and access strategy is resonating well with payers. We remain actively engaged with other major PBNs and health plans, and we expect further expansion of commercial coverage throughout 2024. Ultimately, as this coverage comes online, we anticipate the gap between total demand and field scripts will narrow significantly. As we continue to execute on the launch, our R&D team remains focused on advancing pipeline opportunities for Vinoprazen. In December, we announced that the FDA had accepted our non-erosive GERD daily dosing NDA and assigned the PDUFA target action date of July 19, 2024. We are now only four months away from that decision date. Non-erosive GERD represents the largest subcategory of GERD. with an estimated 15 million US adults diagnosed and treated for the disease annually. If approved, this indication will significantly broaden the Quesna's addressable population, and we believe further accelerate uptake. The review of our application is proceeding as expected, and we continue to plan for July launch in this sizeable indication. As for further development, We anticipate initiating a Phase 3 trial for as-needed non-erosive GERD and a Phase 2 trial for eosinophilic esophagitis later this year. We believe Venoprazan's unique MOA bodes well for success in these two trials. If approved, these additional label extensions will further differentiate Venoprazan relative to PPIs and continue to expand the total addressable market for the Quezna products. We're excited about these programs and anticipate sharing more information about our progress in the future. Later in the call, Molly will further detail our fourth quarter and full year 2023 financials, for which we reported revenues of $682,000 and ended the year with $381 million in cash. Overall, we believe our strong balance sheet will enable us to continue delivering on our launch and development strategies. I've previously stressed several foundational dynamics that are necessary for a potential blockbuster drug. These included a significant addressable market, clear unmet need among patients, demonstrated superiority and physician demand. The qualitative feedback from these early months of launch has bolstered our belief that these elements are present in the GERD market. It now comes down to us executing on our strategy and this team is poised to deliver. These are exciting times for FADM as we continue to make progress on both the commercial and development fronts. This year is sure to be filled with new milestones and will set the foundation for the future of the Quesna. Our pursuit of becoming the number one prescribed acid suppressant in the US is off to a strong start and we remain steadfast in delivering on our strategy of driving blockbuster potential through continued market expansion. I will now turn the call over to Martin to dive deeper into our launch progress. Martin.